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Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects

RecruitingNAAges 18 Years - 65 YearsAllAlcediag
NCT06507787 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Depression is one of the most common mental disorders, affecting nearly 10% of men and 20% of women worldwide. It is associated with a significant increase in mortality, mainly due to suicidal behavior. The Diagnostic and Statistical Manual of Mental Disorders (DSM) defines a Major Depressive Episode (MDE) by a combination of at least five different symptoms, with at least one depressed mood or loss of interest. MDEs can occur in isolation or as part of Major Depressive Disorder (MDD) or bipolar disorder (BD). Bipolar disorders affect 2% of the world's population and are defined by episodes of mania (Type I BD) or hypomania (Type II BD) alternating with episodes of depression and periods of remission. Depression occurring whether in the context of BD or MDD is defined with the same clinical criteria. However, the pharmacological treatments are different in the two groups. In particular,

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with a MDE, moderate to severe (DSM V criteria and MADRS score ≥19) * Age between 18 and 65 years, gender indifferent * Benefitting from health insurance coverage * Having signed an informed consent and agreed to follow the study protocol to completion * Patients for whom there is doubt regarding a bipolar disorder diagnosis, and/or presenting one or more of the following criteria: * More than 3 episodes of MDE in personal medical history * Psychotic symptoms * Family history of bipolar disorder * Onset of the first MDE before the age of 25 * Atypical symptoms or mixed features during depressive episodes * Addiction * Personal history of suicide attempts * Resistance to antidepressants * Postpartum depression within 6 months of birth Exclusion Criteria: * Depression in the context of schizophrenia or autism spectrum disorder * Patient with a well-established diagnosis of bipolar disorder * Patients who is already receiving a mood stabilizer * Severe somatic diseases that may interfere with the follow-up or associated with treatments at risk of secondary manic decompensation * Neurodegenerative diseases * Pregnant women
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What it tests

  • EDIT-B test
  • EDIT-B test (without giving result)
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Where

7 sites
CH Erstein
Erstein, France
AP-HP Corentin Celton
Issy-les-Moulineaux, France
Etablissement Public de Santé Mentale (EPSM) 74
La Roche-sur-Foron, France
Clinique Villa des Roses
Lyon, France
Clinique Le Clos Montaigne
Montrond-les-Bains, France
GHU Paris Psychiatrie et Neurosciences
Paris, France
Clinique Médicale de Ville d'Avray
Ville-d'Avray, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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